INTERCEPT
Study

Study Overview

INTERCEPT is a global, prospective, randomized, blinded-endpoint (PROBE) trial designed to evaluate whether placement of the investigational Vine™ Filter in the CCAs in addition to OAC, can reduce recurrent ischemic stroke associated with anterior large vessel occlusion (LVO), as compared to OAC alone. The eligible patient population includes those with AF and a history of ischemic stroke within the past year.

Study Design

2,000 participants will be randomized 1:1 across 200 sites in 20 countries to receive either:

Treatment Arm

Bilateral Vine™ Filters
Oral anticoagulation (OAC)
6 months of single antiplatelet therapy

Control Arm

Standard of care – OAC alone

Patients assigned to the treatment arm will undergo bilateral implantation within one week of randomization.

All participants will receive standard of care, long-term OAC, with patients assigned to the treatment arm also receiving a P2Y12 inhibitor (e.g., clopidogrel) for 6 months.

Follow-Up

Follow-up will be conducted by phone or in-person visits at:

3 months
6 months
12 months
Every 6 months thereafter until study completion

Study Objective

The INTERCEPT study is designed to evaluate whether placement of the investigational Vine™ Filter in the CCAs can reduce recurrent ischemic stroke associated with anterior LVO in patients with AF and a history of ischemic stroke within the past year.

Study Lead Investigators

Dr. Ashkan Shoamanesh

Co-Principal Investigator

WHRI Global Principal Investigator, Professor of Medicine, Stroke Neurology. McMaster University and Senior Scientist, PHRI, Hamilton, ON, Canada

Dr. P.J. Devereaux

Trial Chair

WHRI CEO and Trial Chair. Professor, Departments of Medicine and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

Dr. Alexander Benz

Co-Principal Investigator

WHRI Global Principal Investigator. Department of Medicine, McMaster University; Department of Cardiology, Hamilton, ON, Canada

Trial National Leaders

Argentina

Julieta Rosales, MD

ENERI, Clínica Sagrada Familia, Buenos Aires

Belgium

Robin Lemmens, MD

University Hospitals Leuven (UZ Leuven), KU Leuven

Brazil

Octávio Marques Pontes Neto, MD

Hospital das Clínicas, Ribeirão Preto Medical School, University of São Paulo (HCFMRP-USP)

Canada

Alexander P. Benz, MD

WHRI Global Principal Investigator. Department of Medicine, McMaster University; Department of Cardiology, Hamilton, ON, Canada

Canada

Ashkan Shoamanesh, MD

WHRI Global Principal Investigator, Professor of Medicine, Stroke Neurology. McMaster University and Senior Scientist, PHRI, Hamilton, ON, Canada

Canada

Jeff Healey, MD

Senior Scientist. Professor of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada

Canada

Luciano Sposato, MD

London Health Sciences Centre, Western University, London, ON

Canada

Michael Kelly, MD

University of Saskatchewan, Saskatoon

Canada

PJ Devereaux, MD

WHRI CEO and Trial Chair. Professor, Departments of Medicine and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

Colombia

Pablo Amaya, MD

Fundación Valle del Lili, Cali

Czech Republic

Robert Mikulik, MD

Tomas Bata Regional Hospital (Krajská nemocnice Tomáše Bati), Zlín

Georgia

Alexander Tsiskaridze, MD

Tbilisi State University; Pineo Medical Ecosystem, Tbilisi

Germany

Roland Veltkamp, MD

Alfried Krupp Krankenhaus, Essen

Greece

George Ntaios, MD

First Propedeutic Department of Internal Medicine, AHEPA University Hospital, Aristotle University of Thessaloniki, Thessaloniki

Greece

Georgios Tsivgoulis, MD

Attikon University Hospital, National and Kapodistrian University of Athens

Italy

Valeria Caso, MD

Department of Neurology, Saronno Hospital, ASST Valle Olona, Saronno

Mexico

Antonio Arauz, MD

Instituto Nacional de Neurología y Neurocirugía Manuel Velasco Suárez, Mexico City

Poland

Bartosz Karaszewski, MD

Medical University of Gdańsk

Portugal

Catarina Fonseca, MD

Hospital de Santa Maria, Faculty of Medicine, University of Lisbon

Spain

Jaime Masjuan Vallejo, MD

Hospital Universitario Ramón y Cajal, Madrid

Switzerland

David Seiffge, MD

Senior Scientist. Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland

United Kingdom

Phil White, MD

Newcastle University; Newcastle upon Tyne Hospitals NHS Foundation Trust

United Kingdom

Rustam Al-Shahi Salman, MD

University of Edinburgh

United States

Hooman Kamel, MD

Weill Cornell Medicine, New York

United States

Jeff Saver, MD

Senior Scientist. Professor of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States

United States

Thanh Nguyen, MD

Boston Medical Center, Boston University Chobanian & Avedisian School of Medicine

Executive Committee Members

Ashkan Shoamanesh, MD

WHRI Global Principal Investigator, Professor of Medicine, Stroke Neurology. McMaster University and Senior Scientist, PHRI, Hamilton, ON, Canada

PJ Devereaux, MD

WHRI CEO and Trial Chair. Professor, Departments of Medicine and Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, ON, Canada

Alexander P. Benz, MD

WHRI Global Principal Investigator. Department of Medicine, McMaster University; Department of Cardiology, Hamilton, ON, Canada

Jeff Healey, MD

Senior Scientist. Professor of Medicine (Cardiology), McMaster University, Hamilton, ON, Canada

Jeff Saver, MD

Senior Scientist. Professor of Neurology, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States

David Seiffge, MD

Senior Scientist. Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Switzerland

Guy Shinar, PhD

Co-founder and CTO, Javelin Medical

Ofer Yodfat, MD

Co-founder and CMO, Javelin Medical

For More INTERCEPT Study Details

Reimbursement

During the INTERCEPT study, the Vine™ Embolic Protection System and procedure are eligible for coverage and reimbursement in the USA by CMS, pursuant to the CMS IDE approval received on July 30, 2024, and in accordance with CMS policy. The likely coding pathway for reporting the procedure is Category III HCPCS code 1091T, which currently maps to APC 1576.